Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light

Trial Information

Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light

OBJECTIVES: I. Determine whether porfimer sodium fluorescence can be used to reveal early
malignant changes in patients with lesions of the oral cavity. II. Investigate whether
porfimer sodium fluorescence can define areas of field cancerization in the oral mucosa,
specifically satellite foci of malignant cells within the margins of an excision. III.
Determine whether uptake of fluorescence is indicative of disease stage.

OUTLINE: Patients receive porfimer sodium IV bolus and are kept in subdued light until
examination with a fluorescence photometer 48 hours later. Patients must avoid sunlight and
other intense lights for an additional 30 days.

PROJECTED ACCRUAL: 20 patients will be accrued per year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Malignant or suspected lesions of the head and neck that are
scheduled for excisional biopsy Lesions no greater than 2 cm in diameter in the mouth,
oropharynx, hypopharynx or larynx Suspected severe dysplasia, carcinoma in situ and/or
invasive carcinoma of the head and neck

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: WBC greater than 3500/mm3 Platelet count greater
than 100,000/mm3 Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal
Alkaline phosphatase no greater than 2 times upper limit of normal Bilirubin no greater
than 2 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: No known hypersensitivity
to porphyrins Not pregnant Fertile patients must use effective birth control

PRIOR CONCURRENT THERAPY: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Wesley L. Hicks, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Federal Government

Study ID:

DS 94-10

NCT ID:

NCT00002964

Start Date:

February 1995

Completion Date:

Related Keywords:

Head and Neck Cancer

stage 0 oropharyngeal cancer

stage 0 laryngeal cancer

stage 0 hypopharyngeal cancer

stage 0 lip and oral cavity cancer

stage I lip and oral cavity cancer

stage I hypopharyngeal cancer

stage I laryngeal cancer

stage I oropharyngeal cancer

Head and Neck Neoplasms

Name

Location

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